On Monday, H.C. Wainwright increased its price target for Aquestive Therapeutics (NASDAQ:AQST) shares to $10.00 from the previous $9.00, while maintaining a Buy rating on the stock. This adjustment follows Aquestive Therapeutics' recent virtual investor event, where the company presented its Adrenaverse technology platform and outlined clinical development plans for its pipeline products.
During the event held late last week, Aquestive showcased AQST-108, a topical gel epinephrine product candidate for alopecia areata (AA), following its lead candidate Anaphylm, a sub-lingual epinephrine film for anaphylaxis. The revised valuation from H.C. Wainwright primarily considers the potential contributions from three of Aquestive's products: Libervant for the treatment of seizure clusters, Anaphylm for anaphylaxis, and AQST-108 for AA.
Aquestive has disclosed its strategy to sequentially launch these products in the U.S. market. The company has slated Anaphylm for a 2026 launch, followed by Libervant in early 2027 for adults with acute repetitive seizures, and is aiming for AQST-108 to potentially hit the market in 2028.
The raised stock price target to $10 reflects the inclusion of AQST-108 in the firm's valuation assessment. H.C. Wainwright assigns a 30% probability of approval for AQST-108 in the AA indication and an 85% probability of approval for Anaphylm in treating anaphylaxis. The analyst reiterated the Buy rating, signaling confidence in Aquestive's development plans and upcoming product launches.
In other recent news, Aquestive Therapeutics has been making significant advancements in its product pipeline. The pharmaceutical company recently completed enrollment for its oral allergen challenge study, a key step in the development of Anaphylm, an epinephrine sublingual film. Furthermore, Aquestive has also completed the first human clinical study for AQST-108, an epinephrine topical gel aimed at treating Alopecia areata.
In addition to these developments, the U.S. Food and Drug Administration (FDA) has approved Aquestive's novel non-injection-based epinephrine device for severe allergic reactions. This marks a significant shift from traditional needle-based treatments and is expected to improve patient compliance.
On the financial front, Aquestive reported a substantial 52% increase in total revenues for Q2 2024, amounting to $20.1 million. This growth was primarily driven by license and royalty revenue. However, the company did note a decrease in manufacturing and supply revenue and an increase in research and development costs, leading to a revised 2024 revenue outlook of $57-60 million and an anticipated non-GAAP adjusted EBITDA loss of $20-23 million.
As for the future, Aquestive is preparing for the commercial launch of Anaphylm and is actively exploring partnerships for distribution. The company expects to submit a New Drug Application for Anaphylm to the FDA in the first quarter of 2025. If approved, a full product launch is anticipated by early 2026.
InvestingPro Insights
Aquestive Therapeutics' recent investor event and H.C. Wainwright's increased price target align with some interesting data from InvestingPro. The company's market cap stands at $429.8 million, reflecting investor optimism about its pipeline. Notably, Aquestive has shown strong revenue growth, with a 51.79% increase in quarterly revenue as of Q2 2024, and a 25.45% growth in the last twelve months. This growth trajectory supports the company's ambitious plans for sequential product launches starting in 2026.
InvestingPro Tips highlight that Aquestive holds more cash than debt on its balance sheet, which could be crucial for funding its clinical development plans. Moreover, the company's stock has shown a strong return over the last three months, with a remarkable 81.54% price total return. This performance aligns with the positive outlook presented at the investor event and the increased price target from H.C. Wainwright.
However, investors should note that Aquestive is not currently profitable, and analysts do not anticipate profitability this year. This is consistent with the company's focus on product development and future launches rather than immediate profitability.
For those interested in a deeper analysis, InvestingPro offers 7 additional tips for Aquestive Therapeutics, providing a more comprehensive view of the company's financial health and market position.
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